Comparison between preoperative clonidine and tranexamic acid on the bleeding during tympanoplasty
Design
In this triple-blind clinical trial study, 62 patients who are candidates for tympanoplasty, referring to Namazi Hospital, will be randomly included in the study. Block randomization will be used to randomly assign people in the study groups. In this method, blocks of 6 (including three people in the intervention group and three people in the comparison group) will be used with a ratio of 1:1.
Settings and conduct
Random Allocation software will be used to generate random sequences. For concealment, the random sequences created in this method are recorded on cards and these cards will be placed in sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, based on the order of arrival of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 60 years who were candidates for tympanoplasty were included in the study after obtaining informed and written consent.
Patients with a history of heart, liver, kidney diseases and severe mental disorders and people treated with tricyclic antidepressants or monoamine oxidase enzyme inhibitors were excluded from the study. patients with high blood pressure those who had systole above 160 mmHg and diastole above 90 mmHg or whose heart rate was less than 50 per minute were excluded from the study.
Intervention groups
90 minutes before the operation, one group was given 200 micrograms of clonidine and the other group was given 250 mg of transgramic acid.
Main outcome variables
Reduce bleeding
The satisfaction level of the surgeon during the operation
Blood pressure and heart rate control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230523058274N1
Registration date:2023-07-07, 1402/04/16
Registration timing:prospective
Last update:2023-07-07, 1402/04/16
Update count:0
Registration date
2023-07-07, 1402/04/16
Registrant information
Name
fatemeh izadabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3837 4599
Email address
fatemehizadabadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effect of oral clonidine and tranexamic acid on bleeding during tympanoplasty surgery
Public title
Comparison of the effects of clonidine and tranexamic acid on the amount of bleeding during tympanoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 are candidates for tympanoplasty
Exclusion criteria:
Treated with tricyclic antidepressants or monoamine oxidase inhibitors
Patients with heart, liver, kidney diseases and severe mental disorders
Patients with systolic blood pressure above 160 mmHg and diastolic blood pressure above 90 mmHg.
Heart rate less than 50 per minute
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In this triple-blind clinical trial study, 62 patients who are candidates for tympanoplasty, referring to Namazi Hospital, will be randomly included in the study. Block randomization will be used to randomly assign people in the study groups (intervention group and comparison group). In this method, blocks of 6 (including three people in the intervention group and three people in the comparison group) will be used with a ratio of 1:1. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method will be used in such a way that the random sequences created in this method are recorded on cards and these cards will be placed in sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, based on the order of arrival of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this three-blind clinical trial study, random allocation concealment method will be used for concealment, in such a way that the random sequences created in this method are recorded on cards and these cards are placed in sealed envelopes. They will be placed in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, based on the order of arrival of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known. The researcher, who is also the outcome assessor, did not know about the grouping, the patients did not know about the grouping and the medicine received, and the data analyzer did not know about the assigned groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Unit 5, 3rd Floor, Mehrdad Building, No. 6, Alley 10, Sanatgar St., Amir Kabir Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7176884349
Approval date
2022-04-03, 1401/01/14
Ethics committee reference number
IR.SUMS.MED.REC.1401.435
Health conditions studied
1
Description of health condition studied
Tympanoplasty
ICD-10 code
H60.10
ICD-10 code description
Cellulitis of external ear, unspecified ear
2
Description of health condition studied
Hemorrhage
ICD-10 code
R58
ICD-10 code description
Hemorrhage, not elsewhere classified
Primary outcomes
1
Description
Bleeding
Timepoint
During tympanoplasty surgery
Method of measurement
A 4-point scoring system was evaluated, 0 = no bleeding, 1 = brief (suction rarely), 2 = heavy bleeding (frequent suction) and 3 = very heavy bleeding (conditions of surgical problem and continuous suction).
2
Description
Hemodynamic variables
Timepoint
It was recorded every 10 minutes before and after pre-drug injection, after induction of anesthesia, after intubation, before surgery and then during surgery.
Method of measurement
توسط پرسشنامه
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 90 minutes before the operation, 200 micrograms of clonidine was administered to one group.
Category
Treatment - Drugs
2
Description
Intervention group: 90 minutes before the operation for one group, 200 micrograms of transgrammic acid was given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Fatemeh Izadabadi
Street address
Department of ENT, Namazi Hospital, Namazi Square, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
Nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Izadabadi
Street address
Unit 5, 3rd Floor, Mehrdad Building, No. 6, Alley 10, Sanatgar St., Amir Kabir Blvd., Shiraz
City
shiraz
Province
Fars
Postal code
7176884349
Phone
+98 71 3837 4599
Email
fatemehizadabadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Vice President of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Izadabadi
Position
Resident ent
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 5, 3rd Floor, Mehrdad Building, No. 6, Alley 10, Sanatgar St., Amir Kabir Blvd., Shiraz
City
SHiraz
Province
Fars
Postal code
7176884349
Phone
+98 917 687 7023
Email
fatemehizadabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Izadabadi
Position
Resident ent
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 5, 3rd Floor, Mehrdad Building, No. 6, Alley 10, Sanatgar St., Amir Kabir Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7176884349
Phone
+98 71 3837 4599
Email
fatemehizadabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Izadabadi
Position
Resident ent
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 5, 3rd Floor, Mehrdad Building, No. 6, Alley 10, Sanatgar St., Amir Kabir Blvd., Shiraz
City
shiraz
Province
Fars
Postal code
7176884349
Phone
+98 71 3837 4599
Email
fatemehizadabadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a part of the data, such as the information related to the main outcome or the like, can be shared.
When the data will become available and for how long
One year after the time of publication
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data will be available only to researchers working in academic and scientific institutions
From where data/document is obtainable
The data will only be available to researchers working in academic and scientific institutions through the following email address. fatemehizadabadi@gmail.com
What processes are involved for a request to access data/document
Only the data related to the main results of the study can be presented to the mentioned people after mentioning the valid reason.